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The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
The specific objective of this six-month study is to evaluate the safety and efficacy of three monthly ophthalmic intravitreal injections of ALG-1001 in human subjects with Wet AMD, and to follow these subjects for an additional four months off-treatment. Three cohorts have been established as part of the study design, utilizing three different doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1.5 mg ALG - 1001 | Experimental | Arm 1.5 mg ALG- 1001 per 50ul |
|
| Arm 2.5 mg ALG -1001 | Experimental | Arm 2.5 mg ALG -1001 per 50ul |
|
| Arm 4.0 mg ALG -1001 | Experimental | Arm 3 4.0 mg ALG -1001 per 50ul |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALG 1001 | Drug | Patients who will receive three, monthly intravitreal injections of 1.5mg, 2.5mg ,or 4.0 /50μl of ALG-1001 in 0.05cc in isotonic saline solution. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Observation of dose limiting toxicity. | The primary endpoint of this study is observation of dose limiting toxicity and the maximum tolerated dose. The determination will be made by ocular adverse events by standard clinical ophthalmic evaluation, visual acuity changes at baseline by slit lamp biomicroscopy, tonometry, indirect ophthalmoscopy/ fundus photography, fluorescein angiography, OCT (optical coherence tomography) central macular thickness. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in OCT central macular thickness | Changes in OCT Central Macular Thickness | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose L Guerrero-Narranjo, MD | APEC Hospital Mexico City | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APEC Hospital La Ceguera | Mexico City | Mexico |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000712274 | risuteganib |
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